Events

Device Recall Emax Consoles 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 The Anspach Effort, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    64973
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1658-2013
  • 사례 시작날짜
    2011-06-24
  • 사례 출판 날짜
    2013-07-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117790
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Graft,bypass,coronary artery - Product Code NAV
  • 원인
    The rpm of the motor handpiece may be less than 80,000 rpm.
  • 조치
    Anspach Effort sent an "URGENT: Medical Device Correction" letter dated June 24, 2011 to their customers via mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a reply form promptly confirming receipt of their letter and return it by fax to the number provided on the form. If any of the affected products were distributed to other services or facilities, please forward this information as appropriate. For questions contact Anspach Customer Support at 800-327-6887 or email customer.support@synthes.com.

Device

Device Recall Emax Consoles
  • 모델명 / 제조번호(시리얼번호)
    SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    HDE
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;
  • 제품 설명
    ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** || Product Usage: || The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM).
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • 제조사 주소
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA